Meningococcal serogroup B vaccine (4CMenB): Booster dose in previously vaccinated infants and primary vaccination in toddlers and two-year-old children |
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| Affiliation: | 1. University of Tampere Medical School, Tampere, Finland;2. University Hospital Hradec Kralove, Hradec Kralove, Czech Republic;3. Novartis Vaccines and Diagnostics S.r.l., Siena, Italy;4. Novartis Vaccines and Diagnostics, Cambridge, MA, United States;1. Public Health England, Public Health Laboratory, Manchester, Manchester Medical Microbiology Partnership, PO Box 209, Clinical Sciences Building II, Manchester Royal Infirmary, Manchester M13 9WZ, UK;2. Immunisation Department, Health Protection Services, Public Health England, Colindale, London NW9 5EQ, UK;3. University of Manchester, Inflammation Sciences Research Group, School of Translational Medicine, Stopford Building, Manchester M13 9PL, UK;1. Institut national de santé publique du Québec (INSPQ), Québec (Québec) G1E 7G9, Canada;2. Centre de recherche du CHU de Québec, Québec (Québec) G1V 4G2, Canada;3. Université Laval, Québec (Québec) G1V 0A6, Canada;4. Direction de santé publique du Saguenay–Lac-St-Jean, Chicoutimi (Québec) G7H 7K9, Canada;5. Ministère de la santé et des Services sociaux, Montréal (Québec) H2M 1L2, Canada;6. Vaccine Evaluation Center, BC Children’s Hospital, University of British Columbia, Vancouver (British Columbia) V5Z 4H4, Canada;1. Immunisation & Countermeasures, Public Health England, 61 Colindale Avenue, London NW9 5EQ, United Kingdom;2. Statistics and Modelling Economics Department, Public Health England, 61 Colindale Avenue, London NW9 5EQ, United Kingdom;3. Section of Inflammation, Repair & Development, National Heart & Lung Institute, Imperial College London, United Kingdom;4. Prof. Elizabeth Miller, Department of Infectious Disease Epidemiology, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom;1. Vaccine and Immunisation Research Group (VIRGo), Murdoch Childrens Research Institute and Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Australia;2. School of Paediatrics and Child Health, University of Western Australia, Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Princess Margaret Hospital for Children, Perth, Australia;3. Vaccinology and Immunology Research Trials Unit (VIRTU), Women''s and Children''s Hospital, School of Paediatrics and Reproductive Health and Robinson Research Institute, The University of Adelaide, Adelaide, Australia;4. Queensland Paediatric Infectious Diseases Laboratory (Qpid), Queensland Children''s Medical Research Institute, Royal Children''s Hospital, University of Queensland, Brisbane, Australia;5. Novartis Vaccines and Diagnostics Inc., Cambridge, MA, USA;6. Novartis Vaccines and Diagnostics S.r.l., Siena, Italy;1. Vigilance and Risk Management of Medicines, Medicines and Healthcare Products Regulatory Agency, London, UK;2. Division of Bacteriology, National Institute for Biological Standards and Control, Hertfordshire, UK;1. Real-time Syndromic Surveillance Team, National Infection Service, Public Health England, 1st Floor, 5 St Philips Place, Birmingham B3 2PW, United Kingdom;2. The Phoenix Partnership (TPP), TPP House, 129 Low Lane, Horsforth, Leeds LS18 5PX, United Kingdom;3. Public Health England West Midlands, 6th Floor, 5 St Philips Place, Birmingham B3 2PW, United Kingdom;4. Immunisation, Hepatitis and Blood Safety Department, National Infection Service, Public Health England, 61 Colindale Avenue, London NW9 5EQ, United Kingdom;5. Royal College of General Practitioners Research and Surveillance Centre, University of Surrey, Section of Clinical Medicine and Ageing, Guildford, Surrey GU2 7XH, United Kingdom |
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| Abstract: | ObjectiveThe multicomponent, recombinant serogroup B vaccine, 4CMenB, is approved in Europe, Canada and Australia from two months of age. We investigated persistence to booster doses at 12 months of age following infant vaccination, and immune response to catch-up vaccination of toddlers and children up to two years of age.MethodsWe assessed persistence of immune responses after one year in participants vaccinated as infants, and responses to two doses at 12–15 or 24–26 months of age in vaccine-naïve children, as serum bactericidal activity with human complement (hSBA) against indicator strains for four vaccine antigens. Adverse events were recorded after each vaccination.ResultsHigh antibody titers were induced against all four 4CMenB components following booster vaccination in infant-primed toddlers and after two doses in previously unvaccinated toddlers or two-year-olds. Antibodies waned over 12 months, particularly those against NZ OMV. Systemic reactogenicity in toddlers was lower than in infants, and lower again in vaccine-naïve two-year-olds. Local reactogenicity was common in all groups.ConclusionsFour infant or two toddler 4CMenB vaccinations elicit immune responses believed to be protective for the first two years of life, which can be boosted. Reactogenicity is lower in toddlers than in infants. |
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| Keywords: | Vaccine Meningococcal serogroup B Infants Toddlers Immunogenicity |
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